CLASS II Drug recall · Reported 19 Aug 2020 · FDA Enforcement Report
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), Eosera recalled
Eosera is recalling Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), Eosera, Inc. 5000 South Freeway Fort, distributed nationwide in the US. The recall was initiated on 4 Aug 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1500-2020
- FDA event ID
- 86171
- Recalling firm
- Eosera, Fort Worth, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2020
- FDA classified
- 13 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 4 Aug 2020 | Recall initiated by company | |
| 13 Aug 2020 | Classified by FDA | +9 days |
| 19 Aug 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations.
Product as listed by the FDA
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
cGMP Deviations.
Which lots are affected?
Lot #: F203071 Exp. SEP 21; F203059 Exp. OCT 21; F193095, F193094 Exp. MAY 21; F193093 Exp. APR 21; F193082 Exp. MAR 21; F193069 Exp. FEB 21; F193061 Exp. JAN 21; F193058, F193054 Exp. DEC 20; F193032, F193030, F193029, F193028, F193027, F193026, F193025, F193024 Exp. AUG 20
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 86171| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Day & Night Pack Ear Itch MD Anti-Itch Spray recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Ear Pain MD Pain Relief Drops with 4% Lidocaine recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Ear Pain MD Pain Relief Drops For Kids recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Eosera
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ear Pain MD Pain Relief Drops For Kids recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ear Pain MD Pain Relief Drops with 4% Lidocaine recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Day & Night Pack Ear Itch MD Anti-Itch Spray recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |